2018 Year In Review: Top 10 Medical Device Regulatory Issues In Canada

A raft of changes to the Canadian medical device regulatory landscape were seen in 2018, several of which were directed at harmonizing Canada's approach to medical device regulation with those of other countries, increasing transparency and providing further guidance on issues affecting the use of software-based technologies in medical devices, including 3D printing and cybersecurity.

1. Health Canada's action plan on medical devices

   Health Canada released its action plan on medical devices (Action Plan), published in part in response to reports in Canada of serious adverse reactions caused by implantable medical devices—in particular, breast implants. The Action Plan sets out a three-part strategy to improve the safety and effectiveness of medical devices and to optimize health outcomes for patients.

   To improve how devices get on the market. Health care professionals and researchers would be able to file applications for authorization to conduct investigational tests, and a new expert advisory committee on women's health issues for drugs and medical devices would complement the existing two scientific advisory committees dedicated to medical devices (one on digital health and the other on cardiovascular devices such as pacemakers). To strengthen monitoring and follow-up. Health Canada currently requires mandatory reporting of medical device incident reports by manufacturers and importers and encourages reporting from healthcare practitioners, hospitals and patients/consumers. The Action Plan proposes to implement mandatory reporting of medical device incidents at hospitals. Health Canada would be able to compel medical device manufacturers to conduct assessments, tests and studies, and inform Health Canada within 72 hours of any risks or warnings published by foreign regulators. To provide more information to Canadians. The Action Plan proposes publishing certain clinical study data provided in medical device submissions and publishing its summaries of approvals to include Class III medical devices, as well as Class IV medical devices. Health Canada is also proposing to launch an accessible public database that contains medical device incident reports in a user-friendly, searchable, online format. The three-part strategy is intended to strengthen processes for the pre-market approvals of medical devices, to provide a unified medical device registry, with a fulsome incident database (containing individual incident reports on post-market medical devices).

   Various parts of the Action Plan are expected to be implemented in 2019, with continued engagement of Canadians through open communication and consultation on specific projects. Medical device manufacturers will want to monitor the progress of the Action Plan to assess which proposals are ultimately adopted and implemented.

2. Updates on Software as a Medical Device (SaMD)

   Canada's Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) held a meeting in January 2018 to discuss the regulatory approach for SaMD. Health Canada took SAP-SaMD's comments into account in releasing a draft SaMD Guidance Document for external consultation with medical device manufacturers, importers, distributors, healthcare professionals, and other stakeholders.

   The draft guidance document on SaMD considers software to be a medical device when 1) it is intended to be used for one or more medical purposes as outlined in the definition of device in the Food and Drugs Act,1 and 2) it performs these purposes without being part of a hardware medical device (i.e., it is not necessary for a hardware medical device to achieve its intended medical purpose).

   Further, based on the intended use of the software, the draft proposes SaMD products would be broadly branded into two categories: Clinical Decision Support Software (CDS) intended for health care providers, and Patient Decision Support Software (PDS) intended for patients and...